Problem: An engineer is asked to design a modular ISO 5 clean room that will be used for filling sterile intermediates into sterile containers. The Fill Room will be assembled in an existing clean room. Assuming no constraints for space or cost, list the design specifications for the following parameters:
a) Number of airlocks/rooms for personnel movement
b) Number of airlocks/rooms for material transfers
c) Required ISO classification of surrounding clean room
d) Air flow direction between Fill Room and surrounding clean room, e.g., Into Fill Room or Out of Fill Room.
e) Pressure differential (inches water) between Fill Room and surrounding room.